Emergency Use Authorization (EUA) - Be Aware, Be Prepared
EUA is an expedited and temporary pathway for the FDA to approve a medical product in times of emergency. Since the COVD-19 pandemic, the FDA has issued nearly 400 EUAs approving a wide spectrum of medical products in the United States market, from vaccines, prescription drugs, biological products, medical devices to personal protective equipment (PPE). These EUAs will be terminated when the pandemic ends; they may also be revoked when the justification of their issuance no longer exist—an action the FDA has started taking since mid-2020.
This webinar will provide an overview of the FDA’s regulations on COVID EUAs and their litigation implications, from the following perspectives:
- The application and issuance of an EUA;
- The considerations for the FDA to revoke an EUA;
- What will likely happen to the product when its EUA is revoked/terminated;
- What manufacturers and developers need to start doing if they have EUA-authorized products on the market.
Jianlin Song| Of Counsel| Wilson Elser
Jianlin Song, MD, JD, is an Of Counsel in the Life Science Litigation Group at Wilson Elser Moskowitz Edelman and Dicker LLP’s San Francisco office. During her 15 years of legal practice, Dr. Song has defended manufacturers of a broad spectrum of life science products, from food supplements and dental adhesives to prescription drugs and Class II medical devices such as joint replacements, electroconvulsive therapy devices and cold therapy devices. She has also defended diagnostic laboratories, fertility centers, and various medical, dental and psychiatric professionals in malpractice cases. Among her many successes, Dr. Song won a motion for summary judgment for the manufacturer of a 3D-printed joint prosthesis in what was likely the first products liability case against a 3D device in California.
In addition to litigation, Dr. Song counsels small businesses, both domestic and international, on pre- and post-marketing compliance issues. She has helped companies from various parts of Asia bring hand sanitizers and other PPEs onto the United States market during the COVID-19 pandemic.